Siemens Radiographic Systems Recalled for Potential Image Flipping Errors
Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is potential misdiagnosis due to image flipping, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max radiographic systems. These systems are equipped with software version VE10 and the SmartOrtho license. The recall is due to a potential software defect where composed images may be flipped before being sent to the Picture Archiving and Communication System (PACS).
If images are flipped, they may be reversed, causing associated annotations such as left/right (R/L) labels to display incorrectly. This error could potentially lead to a misdiagnosis of the patient. The affected units were distributed in the United States to the states of Idaho, Illinois, Michigan, Minnesota, Missouri, North Dakota, and Pennsylvania.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary software updates or repairs to resolve the issue. The recall number for this action is Z-0994-2015.
The recalled product
- Product
- Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 11
Distribution
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